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To drive costs out of the health-care sector, medical logistics providers are adopting supply chain management theories. This organizational chart is as follows and separated into three key areas. Medical Materiel [2] Facilities Management. Biomedical Engineering or Clinical Engineering; These areas are managed by a qualified Director of Logistics.
Examples of products that CDRH regulates include medical devices ranging from tongue depressors and personal protective equipment (PPE) to pacemakers and robotic surgical systems, and medical and non-medical radiation-emitting electronic products such as lasers, x-ray systems, ultrasound equipment, microwave ovens, and color televisions.
The distribution of medications has special drug safety and security considerations. [1] Some drugs require cold chain management in their distribution. [2]The industry uses track and trace technology, though the timings for implementation and the information required vary across different countries, with varying laws and standards.
[14]: 2 Supply chain management was then further defined as the integration of supply chain activities through improved supply chain relationships to achieve a competitive advantage. [12] In the late 1990s, "supply chain management" (SCM) rose to prominence, and operations managers began to use it in their titles with increasing regularity.
Example pharmaceutical packaging line. All aspects of pharmaceutical production, including packaging, are tightly controlled and have regulatory requirements. Uniformity, cleanliness , sterility, and other requirements are needed to maintain Good Manufacturing Practices. Product safety management is vital.
The practice of reusing medical devices labeled for only one use began in hospitals in the late 1970s. [8] After a thorough review by the U.S. FDA in 1999 and 2000, [8] the agency released a guidance document for reprocessed SUDs that began regulating the sale of these reprocessed devices on the market, [9] under the condition that third-party reprocessors would be treated as the manufacturer ...
ISO 13485 Medical devices -- Quality management systems -- Requirements for regulatory purposes is a voluntary standard, [1] published by International Organization for Standardization (ISO) for the first time in 1996, and contains a comprehensive quality management system for the design and manufacture of medical devices.
A supply chain is a complex logistics system that consists of facilities that convert raw materials into finished products and distribute them [1] to end consumers [2] or end customers. [3] Meanwhile, supply chain management deals with the flow of goods in distribution channels within the supply chain in the most efficient manner. [4] [5]